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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) National Institute of Nursing Research (NINR) |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00415545 |
Purpose
Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs. This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure, Congestive |
Behavioral: Fluid Watchers LITE Educational Intervention Behavioral: Fluid Watchers PLUS Educational Intervention |
Phase III |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure |
| Estimated Enrollment: | 710 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Fluid Watchers LITE program
|
Behavioral: Fluid Watchers LITE Educational Intervention
Patients in Fluid Watchers LITE will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written material, a diary, a scale and a telephone follow-up to answer any questions they might have about the educational session.
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2: Experimental
Fluid Watchers PLUS program
|
Behavioral: Fluid Watchers PLUS Educational Intervention
Patients in Fluid Watchers PLUS will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written materials, a diary, a scale, an audio tape of the session and telephone followup. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis, as compared to participants in the LITE program.
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3: No Intervention
Usual care control group
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Heart failure is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is important for individuals with heart failure to closely monitor their symptoms and seek out medical attention when appropriate. Swelling and weight gain are common heart failure symptoms that indicate excess fluid buildup in the body and worsening heart function. Closely monitoring and responding to these symptoms can be a strategic way to prevent heart failure exacerbations. However, many patients ignore symptoms and are reluctant to seek care. Specialized monitoring programs can help heart failure patients to respond more appropriately to their symptoms.
Traditionally, heart failure patients living in rural areas have had limited access to formal monitoring programs. Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms, specifically excess fluid buildup. The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas.
In this 2-year study, 710 participants will be randomly assigned to either the Fluid Watchers LITE program, the Fluid Watchers PLUS program, or a usual care control group. Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis. All participants will record self-monitoring adherence and contact with healthcare providers. Outcome measures will be assessed during either clinic or home visits at study entry and Months 3, 12, and 24, and will include number of emergency department visits, number of physician visits, heart failure severity, and quality of life.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathleen A. Dracup, DNSc | 415-476-1805 | kathy.dracup@nursing.ucsf.edu |
| Contact: Jessica Zegre, MS | 415-476-4745 | jessica.zegre@nursing.ucsf.edu |
| United States, California | |
| University of California, Davis | Recruiting |
| Davis, California, United States, 95817 | |
| Contact: Thomas Nesbitt, MD 916-734-3251 thomas.nesbitt@ucdmc.ucdavis.edu | |
| Contact: Lorraine Pellagrino, MPH 916-734-2327 lorraine.pellegrino@ucdmc.ucdavis.edu | |
| Principal Investigator: Thomas Nesbitt, MD | |
| United States, Kentucky | |
| University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40526 | |
| Contact: Debra Moser, DNSc 859-323-6687 dmoser@uky.edu | |
| Principal Investigator: Debra Moser, DNSc | |
| United States, Nevada | |
| Washoe Health Care System | Recruiting |
| Reno, Nevada, United States, 89523 | |
| Contact: Michele Pelter, PhD 775-982-4221 mpelter@washoehealth.com | |
| Contact: Kimberly Stephens, MS 775-982-4221 kstephens@washoehealth.com | |
| Principal Investigator: Michele Pelter, PhD | |
| Principal Investigator: | Kathleen A. Dracup, DNSc | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco ( Kathleen Dracup/Principal Investigator ) |
| Study ID Numbers: | 423, R01 HL083176-01A1 |
| Study First Received: | December 21, 2006 |
| Last Updated: | September 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00415545 |
| Health Authority: | United States: Federal Government |
|
Heart Failure Patient Education |
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Heart Failure Heart Diseases |
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Cardiovascular Diseases |
